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Procedure

Surgical Tissue Flap for Glioblastoma

N/A
Waitlist Available
Led By John Boockvar, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a Karnofsky Performance Status (KPS) 70% or greater
TPFF and/or pericranial flap is technically feasible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trialassesses the safety of a surgical technique for newly diagnosed GBM patients, with the aim of improving survival.

Who is the study for?
This trial is for adults over 18 with newly diagnosed GBM who are expected to live at least 6 months and can have an MRI. They must be able to undergo a specific surgery, use birth control if of reproductive potential, sign consent, have a KPS of 70% or more, and meet certain lab criteria. Pregnant women, those already treated for GBM or with active infections or other significant health risks are excluded.Check my eligibility
What is being tested?
The study tests the safety of using one's own tissue (TPF or pericranial flap) surgically placed into the brain after tumor removal in patients with GBM. The goal is to see if this method is safe and might help extend the time without disease progression.See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, bleeding, reaction to anesthesia, and issues related to healing at both the donor site and where the tissue is placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a Karnofsky Performance Status (KPS) score of 70 or higher.
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It is possible to perform TPFF and/or pericranial flap procedure.
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You are scheduled to have surgery to remove a known or suspected glioblastoma (GBM).
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A neurosurgeon has determined that at least 80% of the tumor can be removed during surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria
Secondary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Surgical tissue autograft: TPF flap/pericranial flapExperimental Treatment1 Intervention
Use of a pedicled autologous piece of tissue called the temporoparietal fascial (TPF) flap or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
456 Previous Clinical Trials
470,175 Total Patients Enrolled
16 Trials studying Glioblastoma
861 Patients Enrolled for Glioblastoma
John Boockvar, MD3.916 ReviewsPrincipal Investigator - Northwell Health
Northwell Health
13 Previous Clinical Trials
813 Total Patients Enrolled
11 Trials studying Glioblastoma
772 Patients Enrolled for Glioblastoma
5Patient Review
Dr. Boockvar is a life-saver. Quite literally. My brother was diagnosed and in surgery to treat his condition within 24 hours. His bedside manner is comforting, and he is very intelligent. We are grateful to have him in our lives.

Media Library

Surgical Tissue Flap (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03630289 — N/A
Glioblastoma Research Study Groups: Surgical tissue autograft: TPF flap/pericranial flap
Glioblastoma Clinical Trial 2023: Surgical Tissue Flap Highlights & Side Effects. Trial Name: NCT03630289 — N/A
Surgical Tissue Flap (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03630289 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for individuals to take part in this experiment?

"Clinicaltrials.gov currently records that this medical trial is recruiting participants, having been first posted on July 27th 2018 and last modified on October 17th 2022."

Answered by AI

How many individuals will be included in this medical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this study is presently seeking participants. This medical trial was first listed on July 27th 2018 and last revised on October 17th 2022. The research requires 10 subjects from a single location to be recruited."

Answered by AI
~2 spots leftby Mar 2025